A Study Comparing the Efficacy and Safety of IDP-121 and IDP-121 Vehicle Lotion in the Treatment of Acne Vulgaris

NCT ID: NCT02535871

Last Updated: 2015-09-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 800 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2016-07-31

Brief Summary

The primary objective of this study is to compare the efficacy, safety and tolerability of IDP-121 Lotion and vehicle in the treatment of subjects with acne vulgaris.

Detailed Description

This is a multicenter, randomized, double-blind, parallel group, vehicle-controlled, 12-week study to evaluate relative changes in inflammatory and non-inflammatory lesion counts, as well as treatment success using an Evaluator's Global Severity Scale (EGSS) in subjects with moderate to severe acne. IDP-121 is a lotion for the topical treatment of acne.

Conditions

Acne Vulgaris

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

IDP-121 Lotion

IDP-121 Lotion, applied topically to the face, once daily for 12 weeks.

Group Type: EXPERIMENTAL

IDP-121 Lotion

Intervention Type: DRUG

Investigational Product: IDP-121 Lotion

IDP-121 Lotion Vehicle

IDP-121 Vehicle Lotion, applied topically to the face, once daily for 12 weeks

Group Type: PLACEBO_COMPARATOR

IDP-121 Vehicle Lotion

Intervention Type: DRUG

Comparator Product: IDP-121 Vehicle Lotion

Interventions

IDP-121 Lotion

Investigational Product: IDP-121 Lotion

Intervention Type: DRUG

IDP-121 Vehicle Lotion

Comparator Product: IDP-121 Vehicle Lotion

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Male or female at least 9 years of age and older
• Written and verbal informed consent must be obtained.
• Subject must have a score moderate or severe on the Evaluator's Global Severity assessment at the screening and baseline visit
• Pre-menses females and women of childbearing potential must have a negative urine pregnancy test at the screening and baseline visits
• Subjects must be willing to comply with study instructions and return to the clinic for required visits.

Exclusion Criteria

• Any dermatological conditions on the face that could interfere with clinical evaluations
• Any underlying disease(s) or some other dermatological condition of the face that requires the use of interfering topical or systemic therapy or makes evaluations and lesion count inconclusive
• Subjects with a facial beard or mustache that could interfere with the study assessments
• Concomitant use of potentially irritating over-the-counter products

• Minimum Eligible Age: 9 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Valeant Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anya Loncaric, MS

Role: STUDY_DIRECTOR

Valeant Pharmaceuticals

Central Contacts

Anya Loncaric, MS

Role: CONTACT

aloncaric@solta.com

510-259-5284

Other Identifiers

V01-121A-302

Identifier Type: -

Identifier Source: org_study_id